Cybersecurity for Connected Medical Devices

Description

The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Front Cover CYBERSECURITY FOR CONNECTED MEDICAL DEVICES CYBERSECURITY FOR CONNECTED MEDICAL DEVICES Copyright Dedication Contents Preface Acknowledgment One - Introduction to medical device cybersecurity Medical device cybersecurity: a brief history Code complexity Connectivity Patient safety and usability Long device lifetimes Cybersecurity being a shared responsibility Cybersecurity patch delivery Cybersecurity risk management Lack of information sharing Shortage of cybersecurity talent Cybersecurity culture The Product Cybersecurity Organization References Two - Basic cybersecurity concepts A bag full of diamonds Understanding cybersecurity risk Asset System level assets/system assets Subsystem level assets/subsystem assets Vulnerability System level vulnerabilities/system vulnerabilities Design vulnerabilities Unremediated subsystem vulnerabilities Process vulnerabilities Subsystem level vulnerabilities/subsystem vulnerabilities Threat System level threats/system threats Likelihood Severity Subsystem level threats/subsystem threats Cybersecurity risk for patient safety and patient privacy Cybersecurity controls Technical cybersecurity controls Technical control category: cryptography Confidentiality Cryptographic integrity Threats to cryptography Technical cybersecurity control category: authentication Technical control category: authorization Technical control category: access control Technical control category: logging What to observe? When to react? How to prevent the logging system being attacked? Procedural controls Legal controls Summary and key takeaways References Three - Regulatory overview Introduction Regulations, quality, and the medical device quality management system Structure of a medical device quality management system Summary of regulatory requirements for cybersecurity Shared responsibility Secure design principles for safety Security management Security requirements Secure by design Secure implementation Security verification and validation testing Management of security-related issues Secure design principles for privacy Cybersecurity labeling Premarket and postmarket cybersecurity risk management Premarket Postmarket Information sharing Coordinated vulnerability disclosure Proactive vulnerability monitoring Patching and communication Standards Healthcare delivery organization–specific cybersecurity standards Medical device manufacturer–specific cybersecurity standards Supporting medical device manufacturer–specific standards Integrating regulatory requirements into a medical device quality management system Step 1: scope the cyber-QMS Step 2: determine regulations, guidance, and standards Step 3: create a set of technical and procedural controls based on the identified regulations, guidance, and standards Step 4: align with existing process architecture Step 5: create a quality plan Summary and key takeaways References Four - The Product Cybersecurity Organization Introduction The NIST cybersecurity framework People: building up a Product Cybersecurity Organization Global shortage of cybersecurity professionals Specializations needed for medical device cybersecurity Culture Develop proper organizational structure within business units Know what you are looking for Be flexible Process and tools: building up a Product Cybersecurity Organization Summary and key takeaways References Five - Cybersecurity risk management-I Introduction Threat modeling There are two threat models Running example: the Zeus infusion pump Identifying the system Subsystem (software and hardware) cybersecurity risk modeling Subsystem threat modeling Identify subsystem assets (Cybersecurity Bill of Materials or CBOM) Identify subsystem vulnerabilities and threats Subsystem cybersecurity risk assessment Defining risk acceptability at subsystem level Defining risk response at subsystem level System cybersecurity risk modeling System threat modeling Identify system assets Identify system vulnerabilities Identify system threats System cybersecurity risk assessment Severity of a system threat Likelihood of a system threat Timely observability Summary and key takeaways References Six - Cybersecurity risk management-II Introduction Defining risk acceptability at system level Defining risk response for system threats Primary controls Secondary controls Defining risk response for subsystem–level threats that pose “unacceptable” risk at the subsystem level Risk–benefit analysis A method for assessing system risk of risk responses A process for continually evaluating risk throughout the product lifecycle Summary and key takeaways References Seven - Cybersecurity design engineering Introduction Secure requirements Master set of technical controls System authentication User authentication Requirements for exact mechanism used for establishing user identity Requirements for provisioning/restoring user credentials Secure updates Session integrity and confidentiality Session management Data integrity and confidentiality in motion Data integrity at rest Data confidentiality at rest Code and data authenticity during execution Key and credentials management Key and credentials strength Keys and credentials secure storage Requirements for securing private/shared symmetric keys Requirements for securing public keys Role-based authorization and access control Emergency access Restrict access Denial-of-service protection Code updateability Secure configuration Cybersecurity logging and monitoring Cybersecurity alerting Secure system specification and implementation Secure system verification and validation Secure system verification Positive coverage Negative coverage Secure system validation Static analysis Dynamic analysis Malware detection and analysis tools Penetration testing Labeling for security Summary and key takeaways References Eight - Supply chain cybersecurity risk management, secure product development, secure manufacture, vulnerability m ... Introduction Product supply chain risk management Product supply chain cybersecurity risk modeling (Fig. 8.1) Create inventory of assets Model cybersecurity risk from third-party components Formulate risk responses Secure product development Secure manufacture Secure manufacture Vulnerability management Vulnerability monitoring Product monitoring Internal product verification and validation Product returns and servicing Customer complaints Supplier notifications Public sources of product-specific vulnerabilities Coordinated vulnerability disclosure Threat intelligence feeds Cybersecurity patch management External communication Corrective and preventive action Cybersecurity training Summary and key takeaways References Nine - Product security governance and regulatory compliance Introduction Product security governance Cybersecurity strategy Criteria for identifying regulations, standards, and guidance that drive cybersecurity strategy Method for defining and maintaining mapping from regulations, standards, and guidance to set of technical and procedural co ... Method for gap and noncompliance assessment Method for gap and noncompliance remediation Defining and maintaining roles and responsibilities Cybersecurity management review Operational metrics Design metrics Standards and regulatory compliance Regulatory submissions Summary and key takeaways References Afterword Index A B C D E F G H I J K L M N P Q R S T U V W Z Back Cover